Newly Required FDA Cosmetic, Food and Medical Device Data Elements in ACE
- June 10, 2016
Shapiro is fully programmed for all FDA filings and has been actively filing FDA though ACE for many months. Under the ACE platform FDA is requiring additional, and in many cases new information, to be submitted in import entries. Specifically all entries for FDA Food, Cosmetics and Medical Devices are affected.
Below is a list and brief description of the new required elements. Our goal is to assure all of our customers are as prepared as possible, and that there are no delays in facilitating the release of their products. If you have any questions about these new requirements please reach out to your Shapiro Import Analyst for further information.
FDA Cosmetics
- Manufacturer DUNS number
- Delivery Party: S. party that physically receives the goods.
FDA Food Products
- Manufacturer DUNS number
- Delivery Party: S. party that physically receives the goods.
- Temperature Information for the goods
- Lot Number
- Agency Processing Codes:
| NSF: Natural State Food |
| PRO: Processed Food |
| FEE: Animal Food (includes pet food, medicated feed, feeds |
| ADD: Additives and Colors |
| DSU: Dietary Supplements |
- Intended Use Code: Possible codes shown in the table below depending on Agency Processing Code.
|
INTENDED USE CODES Food with Prior Notice (All Agency Process except *CCW) *Ceramic Ware and other food contact substances |
||
| *CFSAN Regulated Products | Intended Use Code | Intended Use Name |
|
For research use as Human Food |
260.000 | For research use as Human Food |
|
For research use as an Animal Food |
015.000 | For research use as an Animal Food |
|
Personal Importation |
210.000 | For personal use as Human Food |
| *Center for Food Safety & Applied Nutrition | ||
|
INTENDED USE CODES Food No Prior Notice (Agency Process = *CCW) *Ceramic Ware and other food contact substances |
||
| *CFSAN Regulated Products | Intended Use Code | Intended Use Name |
|
For research use as Human Food |
260.000 | For research use as Human Food |
|
For research use as an Animal Food |
015.000 | For research use as an Animal Food |
|
Personal Importation |
210.000 | For personal use as Human Food |
| *Center for Food Safety & Applied Nutrition | ||
FDA Medical Devices
- Trade Name of Device
- Manufacturer DUNS number
- Delivery Party: S. party that physically receives the goods.
- Affirmation of Compliance Codes:
- DFE (Device Foreign Exporter)
- DEV (Device Registration Number)
- LST (Device Listing Number), others vary depending on type of device
- Intended Use Code: Possible codes shown in the table below.
| Intended Use Definition | Intended Use Code | Relevant Medical Device Import Scenarios |
| For Human Medical Use as a Medical Device | 081.001 |
Standard import of a medical device, accessories, or components regulated as a finished device Import of refurbished device Import of a reprocessed device |
| For Human Medical Use as a Medical Device for Domestic Refurbishing | 081.002 | N/A |
| For Human Medical Use as Medical Device–domestically manufactured device that is part of a medical device convenience kit. | 081.003 | N/A |
| For Human Medical Use as a Medical Device –foreign manufactured device that is part of a medical device convenience kit | 081.004 | N/A |
| Importation of a device constituent part (finished device) for use in a medical product regulated under a drug (CDER) application type (e.g., for use in an NDA/ANDA/BLA drug-device combination product). | 081.005 | N/A |
| Import of a medical device under enforcement discretion provisions per final guidance: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf | 081.006 |
Applicable product codes for CBP business rule: 80O – – UG; 86N – – FF 86N – – FG; 80N – – XQ 90L – – MB; 90L – – MD |
| For Personal Use as a Non-Food Product – for personal use as a medical device | 100.000 | N/A |
| For Public Exhibition or Display as a Non-Food Product | 110.000 |
Includes import of device for trade show
|
| For Charitable Organization Use as a Non-Food Product | 140.000 | N/A |
| Component for further manufacturing into a finished medical device | 081.007 | N/A |
| Importation of a device component for use in a medical product regulated under a drug (CDER) application type (e.g., for use in an NDA/ | 081.008 | N/A |
| For Repair of a Non-Food Product | 170.000 | Repair of medical device and re-exportation |
| For Research and Development as a Non-Food Product – For research and development as a medical device | 180.010 | Import of research or investigational use in vitro diagnostic device |
| For Research and Development as a Non-Food Product – for bench testing or nonclinical research use | 180.014 |
Import of a device for non-clinical use/bench testing Import of device sample for customer evaluation |
| For Research and Development as a Non-Food Product – import of a medical device for clinical investigational use | 180.015 | N/A |
| Import of a device that is US goods returned for refund/overstock (to manufacturer) | 920.001 |
Refund/overstock Bench Testing Corrective Action Prevention Action (CAPA) Plan Investigation Recall |
| Import of a device that is US goods returned for sale to a third party | 920.002 | N/A |
| Import of a Compassionate Use/Emergency Use Device | 940.000 | N/A |
| Import of a single-use device for domestic reprocessing | 950.001 | N/A |
| Import of a multi-use device for domestic reprocessing | 950.002 | N/A |
| Import for Export | 970.000 |
Import of a medical device for further processing and re-exportation Import of medical device or accessory for further manufacturing into an export only medical device |
| Import for Export | 970.001 | Import of a medical device component for further manufacturing into an export only medical device |